Comparison of Drugs on Headache Treatment After ECT Treatment

Mustafa Kemal University

Status and phase: Unknown; Phase 4

Conditions: Mental Disorders

Treatments: Drug: Deksketoprofen trometamol; Drug: Paracetamol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03830398

2018/171

Details and patient eligibility

About

Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT.

Full description

Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems. The most common seen adverse effect is headache with approximately 60% incidence. The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol. The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who were admitted for ECT and gave informed written consent were included in the study.

Exclusion criteria

• Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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225 participants in 3 patient groups, including a placebo group

Paracetamol

Active Comparator group

Description:

Parol group: intravenous infusion in 30 min Generic name: Parol Dosage form: intravenous Dosage: 1 gr Frequency: preop one dose only Duration: For one week

Treatment:

Drug: Paracetamol

Deksketoprofen trometamol

Active Comparator group

Description:

Sertofen group: intravenous infusion in 30 min Generic name: Sertofen Dosage form: intravenous Dosage: 50 mg Frequency: preop one dose only Duration: For one week

Treatment:

Drug: Deksketoprofen trometamol

Placebo

Placebo Comparator group

Description:

Placebo group: intravenous infusion in 30 min Generic name: Serum physiologic Dosage form: intravenous Dosage: 100 ml Frequency: preop one dose only Duration: For one week

Treatment:

Drug: Placebo